Indian Standard Details

    Print

IS Number : IS/ISO 14971 : 2019
ISO 14971:2019

IS Title [Eng-Hn] : Medical devices - Application of risk management to medical devices First Revision
No of Revision : 1
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 14 ( Hospital Planning )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Health care facilities
Sub Sub Group : Quality Management of hospitals
Aspects: Code of Practice
Certification:
Ministry : Ministry of Consumer Affairs, Food and Public Distribution - Department of Food and Public Distribution
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 14971 : 2019
Organisation :

Indian Standards Refered In IS IS/ISO 14971 : 2019 :
SNo IS Number Title Technical Committee
Standard contains no Cross Referenced Indian Standard.
Standard contains no Cross Referenced Indian Standard.
International Standards Refered In IS/ISO 14971 : 2019 Standard contains no Cross Referenced International Standard.
IS/ISO 14971 : 2019 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 3565 : 1966 Rubber Teats for Feeding Bottles PCD 13
2 IS 3025 : Part 71 : 2021 Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 71 Determination of Dissolved Cations Using Ion Chromatography CHD 36
3 IS 16143 : Part 6 : 2021 Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision) PCD 7
4 IS 17567 : Part 1 : 2021 ISO TS 19807-1:2019 Nanotechnologies Magnetic nanomaterials Part 1: Specification of characteristics and measurements for magnetic nanosuspensions MTD 33
5 IS 17652 : 2021 Soy Butter FAD 16
6 IS 17667 : 2021 Vegetable fats and oils Determination of phospholipids content in lecithins by HPLC using a light-scattering detector FAD 13
7 IS 16048 : Part 2 : 2021 SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES SECONDARY SEALED CELLS AND BATTERIES FOR PORTABLE APPLICATIONS PART 2: NICKEL-METAL HYDRIDE ETD 11
8 IS 1248 : Part 9 : 2021 Direct acting indicating analogue electrical measuring instruments and their accessories Part 9: Recommended test methods ETD 12
9 IS/ISO 26262 : Part 5 : 2018 Road vehicles Functional safety Part 5: Product development at the hardware level TED 11
10 IS 5501 : 2021 Specification for Pneumatic Tyred Roller (first revision) MED 7
11 IS/ISO 26262 : Part 11 : 2018 Road vehicles Functional safety Part 11: Guidelines on application of ISO 26262 to semiconductors TED 11
12 IS/ISO/TR 24971 : 2013 Medical devices - Guidance on the application of ISO 14971 MHD 14
13 IS 1205 : 2022 METHODS FOR TESTING TAR AND BITUMINOUS MATERIALS - Determination of Softening Point Ring and Ball Apparatus IS 1205 PCD 6
14 IS 101 : Part 2 : Sec 4 : 2022 Methods of sampling and test for paints varnishes and related products Part 2 Test on liquid paints chemical examination Section 4 Determination of volatile organic compound voc and or semi volatile organic compounds svoc content gas-chromatographic (First Revision) CHD 20
15 IS 14473 : Part 3 : 2022 CRANES INSPECTIONS -- PART 3 TOWER CRANES MED 14
16 IS 17847 : 2022 Bensulfuron Methyl technical- Specification FAD 1
17 IS 17881 : Part 1 : 2022 Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin TXD 32
18 IS/ISO 14155 : 2011 Clinical investigation of medical devices for human subjects - Good clinical practice MHD 19
19 IS 14268 : 2022 Uncoated stress relieved low relaxation seven-wire (ply) strand for prestressed concrete -Specification (Second Revision) CED 54
20 IS 1885 : Part 84 : 2022 Electrotechnical Vocabulary Part 84 Terminology Concerning Fire Tests for Electrotechnical Products (Third Revision) LITD 1
21 IS 11047 : 2022 TEXTILES POSTAL GREEN CASH BAGS SPECIFICATION TXD 20
22 IS 17706 : 2022 PULL HANDLES SPECIFICATION CED 15
23 IS 17883 : 2022 Geological Exploration for Tunnels Guidelines WRD 5
24 IS 1713 : 2022 Decorticated Groundnut Oilcake as Livestock Feed Ingredient � Specification FAD 5
25 IS 3161 : 2022 Gram Chuni as Livestock Feed Ingredient � Specification FAD 5
26 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
27 IS 13450 : Part 1 : SEC 2 : 2018 Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision) MHD 15
28 IS 13450 : Part 1 : Sec 6 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Collateral standard: Usability MHD 15
29 IS 13450 : Part 1 : Sec 10 : 2019 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers MHD 15